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Solara Active Pharma Sciences (Solara) has successfully completed the inspection carried out by the US Food and Drug Administration (US
FDA or Agency) at its Cuddalore facility (Tamil Nadu).
The Agency, with its designated investigators, inspected the Cuddalore facility between 31 July 2023 – 04 August 2023. The inspection established that the facility is in an “Acceptable State of Compliance” with Zero Form 483 inspectional observations from the Agency.
With this successful inspection outcome, the current inspection classification of Cuddalore site shall be reinstated to NAI (No Action Indicated).
The Cuddalore API site is a multi-product facility, caters wide range of APIs to various regulated markets across the globe, including U.S., Europe, Japan and other markets.
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